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FDA 510(k)

Agem Ag Mesh Dressing with Silver

N.º K: K152544 · 2016-05-23

SolicitanteShenzhen Yuanxing Nano-Pharma Co., Ltd.
Fecha de decisión2016-05-23
Código de productoFRO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Agem Ag Mesh Dressing with Silver is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Yuanxing Nano-Pharma Co., Ltd.. It received FDA 510(k) clearance on 2016-05-23 under 510(k) number K152544. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Agem Ag Mesh Dressing with Silver?

Agem Ag Mesh Dressing with Silver is a medical device that received FDA 510(k) clearance on 2016-05-23. The listed applicant is Shenzhen Yuanxing Nano-Pharma Co., Ltd.. The 510(k) number is K152544.

When did Agem Ag Mesh Dressing with Silver receive FDA 510(k) clearance?

Agem Ag Mesh Dressing with Silver received FDA 510(k) clearance on 2016-05-23, under 510(k) number K152544.

Who is the listed applicant for Agem Ag Mesh Dressing with Silver?

The FDA 510(k) record lists Shenzhen Yuanxing Nano-Pharma Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Agem Ag Mesh Dressing with Silver?

The FDA product code for Agem Ag Mesh Dressing with Silver is FRO. This falls under the Anesthesiology category.

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Dispositivos relacionados (Código: FRO)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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